Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement

Pancreas Cancer Clinical Trial

— PACER  

Official title:

PACER (Pancreatic AdenoCarcinoma With Electron Intraoperative Radiation Therapy): A Phase II Study of Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716531
• Other study ID #: 18-267
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: November 2023

Study information

• Verified date: September 2022
• Source: Massachusetts General Hospital
• Contact: Theodore S. Hong, MD
• Phone: 617-724-4000
• Email: tshong1[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is studying an intervention as a possible treatment for pancreatic cancer.

Description:

In this research study, the investigators are researching how well IORT during surgery works in treating pancreatic cancer after 3-6 months of chemotherapy and external radiation therapy. IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy. The investigators believe that the administration of IORT after 3-6 months of chemotherapy will help to stop the cancer cells from growing.

The FDA (the U.S. Food and Drug Administration) has not approved IORT for this specific disease but it has been approved for other uses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• ECOG Performance Status 0-1

• Previous completion of at least three (3) months of EITHER gemcitabine plus nab-paclitaxel OR FOLFIRINOX (5-fluorouracil, oxaliplatin, irinotecan and leucovorin)

• Previous completion of either stereotactic-body radiation therapy (SBRT) (minimum 24 Gy) or external beam irradiation (EBRT) (minimum 45 Gy)

• Participation in any investigational drug study within 4 weeks preceding the start of study treatment is PERMITTED.

• Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after IORT.

• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after IORT. Women who are not of childbearing potential, i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Evidence of disease progression or distant metastases.

• Pregnant or lactating women

• Treatment for other invasive carcinomas within the last five years who are at greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.

• Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• An active infection requiring systemic therapy

• Other serious medical conditions that the investigator feels might compromise study participation

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• IORT
IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	University of North, Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of California, Irvine	Irvine	California
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	Mayo Clinic, Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	IntraOp/Mobetron

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 Year Overall Survival	Overall survival is defined as the time from IORT to death due to any cause, or is censored at the date of last follow-up, when applicable.	2 years
Secondary	Median Progression Free Survival	Progression-free survival is defined as the time from the date of IORT until the first evidence of local progression or distant metastasis (determined by imaging or biopsy) or death, and is censored at date of last follow-up when applicable.	2 years
Secondary	Local Control	Local control is the absence of local failure, defined as evidence of growth or regrowth of the primary tumor and/or extension to regional lymph nodes that meets criteria for progressive disease beyond that present in pre-IORT imaging studies.	2 years
Secondary	Adverse events associated with IORT	Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).	2 years